Children with gender dysphoria, government sets up register on prescriptions and patient data
Database on drugs to block puberty and on masculinising and feminising hormones, but also on information on the mental and physical health of young people to be diagnosed by multidisciplinary teams, launched at Aifa
2' min read
2' min read
It is not a stop to drugs and hormones for minors with gender dysphoria, but it is certainly a 'crackdown', the one dictated by the bill approved by the Council of Ministers at the proposal of Eugenia Roccella (Family and Natality) and Orazio Schillaci (Health).
Explaining the rationale behind the measure is a note from the Ministry for Family, Birth and Equal Opportunities: "In the light of the current provisions of the Italian Medicines Agency (Aifa) and the opinion of the National Committee for Bioethics (Cnb)," it reads, "and in view of the debate that has developed on the subject at the international level and the insufficiency and inhomogeneity of data on treatments for gender dysphoria in minors on the Italian national territory - which has led to the establishment of a technical panel whose work is still in progress - the bill introduces provisions for the effective monitoring of data and for the protection of the health of minors.
The Aifa register
.The text in three articles and with a financial invariance clause provides for the activation at the Italian Medicines Agency of a register for the prescription and dispensation of medicines that, like triptorelin - currently paid for by the National Health Service in off-label mode - have the effect of blocking puberty and also of masculising and feminising hormones.
All these products can in any case only be dispensed by hospital pharmacies. Aifa will have ninety days from the entry into force of the law: the stated aim of the register is 'to monitor the correct use of the drug', taking into account the specific indications that the Ministry of Health is called upon to prepare within thirty days of the law becoming operative.
More than one register
.Not only: the register must 'contain at least elements and information concerning the decision-making process for prescribing drugs and hormones', including the 'documented outcomes of previous psychological, psychotherapeutic, and possibly psychiatric courses, any diagnosed comorbidities, clinical monitoring, and follow-up'. All this data will be taken into account in the report that Aifa is required to submit to the Ministry of Health every six months.
